Label: COVER RECOVER SPF 30 BEIGE- zinc oxide and titanium dioxide cream

  • NDC Code(s): 62742-4119-1, 62742-4119-2
  • Packager: Allure Labs, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 5, 2017

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Zinc Oxide 8.5%

    Titanium Dioxide 6.5%

  • PURPOSE

    Sunscreen

  • INDICATIONS & USAGE

    Uses: Helps prevent sunburn.

    if used as directed with other sun protection measures, decreases the rsk of skin cancer and early skin aging caused by the sun.

    post treatment camouflage for skin needling and rejuvenation procedures.

  • DOSAGE & ADMINISTRATION

    Directions: Apply immediately after treatment procedures, to dry clean skin, as a acamouflage for minor skin trauma. Apply daily after your skincare regime with DPDermaceuticals, as a corrective sunscreen foundation.

    Sun protection measures: For sunscreen use

    Apply for liberally 15 minutes before sun exposure. Re-apply every 2 hours, or after swimming or drying off with a towel. Prolonged exposure to the sun should be avoided, especially from 10:00am - 2:00pm. Suitable clothing such as long-sleeved shirt, hats, and sunglasses should be worn at all times in the sun. Use on children under 6 months ask a doctor. 

  • WARNINGS

    For external use only.

    do not use on damaged or broken skin.

    when using this product keep out of eyes.

    rinse with water to remove.

    stop use and ask a doctor if rash occurs.

    keep out of reach of children.

  • OTHER SAFETY INFORMATION

    Protect the product in this container from excessive heat and direct sun.

  • INACTIVE INGREDIENT

    Cyclopentasiloxane, Dimethicone, Water (Aqua), Polyglyceryl-3-Polydimethylsiloxyethyl Dimethicone, Dimethicone/PEG-10/15 Crosspolymer, Bismuth Oxychloride, Butylene Glycol, Hydroxypropylcocoate PE-8 Dimethicone, Polyglyceryl-2 Diisostearate, Hydrated Silica, Mica, Stearic Acid, Aluminum Hydroxide, Dimethicone/Vinyl Dimethicone Crosspolymer, Jojoba Esters, Cyclohexasiloxane, Biosaccharide Gum-1, Isohexadecane, PEG/PPG-18/18 Dimethicone, Glycerin, Pyrus Malus (Apple) Fruit Extract, Vitis Vinifera (Grape) Seed Extract, Mentha Piperita (Peppermint) Extract, Menthyl PCA, Sodium Hyaluronate, Copper Lysinate/Rolinate, Allantoin, Beta-Carotene, Hydrolyzed Vegetable Protein, Tocopherol, Adenosine Triphosphate, Saccharomyces Lysate Extract, Acetyl Tyrosine, Methylglucoside Phosphate, Retinyl Palmitate, Ascorbyl palmitate, Phospholipids, Proline, Ethyl menthane carboxamide, Triethoxysilylethyl Polydimethylsiloxyethyl HexylDimethicone, Phenoxyethanol, Ethylhexylglycerin, Hexylene Glycol, Caprylyl Glycol, Fragrance (Parfum), Triethoxycaprylysilane, Limonene, Linalool, citral, May contain:(+/-) Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499)

  • PRINCIPAL DISPLAY PANEL

    DML42141/GMP Certified.

    manufactured in USA for 

    EQUIPMED EUROPE LONDON, W1H 1PJ

    Made exclusively for www.dermapenworld.com

    Image CR SPF30 20

  • INGREDIENTS AND APPEARANCE
    COVER RECOVER SPF 30 BEIGE 
    zinc oxide and titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4119
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION85.0 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE65.0 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    WATER (UNII: 059QF0KO0R)  
    POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    HYDROXYPROPYLCOCOATE PEG-8 DIMETHICONE (UNII: 8TE0BZU36S)  
    POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    MICA (UNII: V8A1AW0880)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)  
    TRIEPOXYCYCLOHEXASILANE (UNII: 066Q83563R)  
    BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    APPLE (UNII: B423VGH5S9)  
    VITIS VINIFERA SEED (UNII: C34U15ICXA)  
    MENTHA PIPERITA (UNII: 79M2M2UDA9)  
    MENTHYL DL-PYRROLIDONECARBOXYLATE (UNII: 8P18J856U2)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    ALLANTOIN (UNII: 344S277G0Z)  
    .BETA.-CAROTENE (UNII: 01YAE03M7J)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ADENOSINE TRIPHOSPHATE (UNII: 8L70Q75FXE)  
    SACCHAROMYCES LYSATE (UNII: R85W246Z1C)  
    N-ACETYLTYROSINE (UNII: DA8G610ZO5)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
    PROLINE (UNII: 9DLQ4CIU6V)  
    ETHYL MENTHANE CARBOXAMIDE (UNII: 6S7S02945H)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+)- (UNII: F4VNO44C09)  
    CITRAL (UNII: T7EU0O9VPP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62742-4119-21 in 1 CARTON12/05/2017
    1NDC:62742-4119-120 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35212/05/2017
    Labeler - Allure Labs, Inc (926831603)
    Registrant - Allure Labs, Inc (926831603)
    Establishment
    NameAddressID/FEIBusiness Operations
    Allure Labs, Inc926831603manufacture(62742-4119)